Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)

Phase 3 Active not recruiting 302 enrolled European Myeloma Network B.V. Amgen · collab EMN Trial Office S.r.l. Impresa Sociale · collab Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This protocol is a phase III study designed to compare the efficacy and the safety of Isa-KRd induction, transplant, Isa-KRd post ASCT consolidation and Isa-KRd light consolidation vs KRd induction, transplant, KRd post ASCT consolidation and KRd light consolidation After confirmation of eligibility criteria patients will be randomized to one of the 2 treatment groups in a 1:1 randomization ratio.

Timeline

Start: 2020-09-25
Primary completion: 2025-07-31
Completion: 2032-12-31

Publications

Gay F, Roeloffzen W, Dimopoulos MA, Rosinol L, van der Klift M, Mina R, Oriol A, Katodritou E, Wu KL, Rodriguez Otero P, Hajek R, Antonioli E, van Duin M, D'Agostino M, Martinez-Lopez J, van Leeuwen-Segarceanu EM, Zamagni E, van de Donk NWCJ, Weisel KC, Pour L, Radocha J, Belotti A, Schjesvold F, Blade J, Einsele H, Sonneveld P, Boccadoro M, Broijl A. Isatuximab, carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma: a randomized phase 3 trial. Nat Med. 2026 May;32(5):1773-1782. doi: 10.1038/s41591-026-04282-0. Epub 2026 Apr 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isatuximab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Carfilzomib	Other / unclassified	56 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Lenalidomide	Other / unclassified	10 mg	Oral

Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)

Summary

Timeline

Publications

Drugs

Indications